Relation Between Human Epididymis Protein 4 (HE4) and Endometrial Pathology in Patients With Postmenopausal Bleeding

NCT03558321 | Completed DMC

• 1 other identifier: 37
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

All patients included in the study had single or multiple episodes of postmenopausal bleeding with an endometrial thickness of more than 5mm. full history, general and local examination were done. Transvaginal ultrasound (TVS) was performed .The uterus was scanned in the sagittal plane. The double-layer ET was measured at the widest point between the endometrial-myometrial interfaces.the level of HE4 was measured. All women underwent hystrospopic guided endometrial biopsy. Definitive management was later performed in the form of total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection and histopathological examination.

Conditions

Postmenopausal Bleeding

Outcome Measures

Primary Outcomes (1)

• endometrial pathology

  pathological examination of the endometrial tissue

  3 days after hystroscopy

Study Arms (1)

post menopausal bleeding

EXPERIMENTAL

women with postmenopausal bleeding and endometrial thickness more than 5 mm

Procedure: Hysteroscopic guided fractional curretage; Procedure: total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection

Interventions

Hysteroscopic guided fractional curretage PROCEDURE

Under general anaesthesia , evaluation of the endometrial cavity was done followed by biopsy of the whole endometrial tissue

post menopausal bleeding

total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection PROCEDURE

Through abdominal incision , removal of the whole uterus , both tubes and ovaries and in some cases pelvic lymph nodes removal was done

post menopausal bleeding

Eligibility Criteria

• Age: 50 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with single or multiple episodes of postmenopausal bleeding Endometrial Thickness ≥ 5mm

You may not qualify if:

• History of other Malignancies
• Patients on chemo and/or radiotherapy
• Patients on tamoxifen
• Patients unfit for surgical intervention
• Patients on HRT or other hormonal treatment

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

Study Officials

• Ahmed Maged

  professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: June 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: May 1, 2018
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

EG (1)